Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Western Sky Medical Research
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time of study in the season of the study.

• Allergy skin tests positive for the airborne allergens present at the study time within the past 12 months.

• A score of 2 or more on the NRQLQ of the Rhinitis Quality of LIfe Questionnaire.

• Active allergic rhinitis on 4 of 7 days during run-in week, and evidence on sleep scales of drowsiness on 3 of 7 days.

• Ability to read, understand and give informed consent.

• Ability to understand and carry out responsibilities of the study

Exclusion Criteria:

• Any chronic disease or other acute disease, which could influence central nervous system.

• The use of any medication, which could affect central nervous system function.

• Unwillingness to participate in the study.

• Inability to understand testing procedures or use of medication.

• Hypersensitivity to fluticasone or vehicle of nasal sprays.

• Any sleep disorders including obstructive sleep apnea.